Replaceable Cartridge for Allergy Testing System
A replaceable cartridge for use in a minimally invasive allergy testing system includes a microneedle array; encapsulated allergens, and packaging to hold the array in alignment with the allergens. A method of manufacturing a replaceable cartridge is disclosed. A formable layer is placed on a mold having cavities and vacuum lines coupled to the cavities. Heat is applied to the formable layer and a negative pressure is applied to the vacuum lines to wrap the cavities with the formable layer. The wrapped cavities are filled with allergens. The filled cavities are covered with a plastic cover to form an encapsulated allergen assembly. A removable seal is applied over the plastic cover. A microneedle array having a substrate and at least one microneedle is formed. An energy storage device is coupled to the substrate to form a microneedle array assembly. The encapsulated allergen assembly is coupled with the microneedle array assembly.
This application claims priority to U.S. provisional patent application No. 60/698,202 filed Jul. 11, 2005, the specification of which is hereby officially incorporated by reference in its entirety,
FIELDThe claimed invention generally relates to systems for testing for medical conditions and, more particularly, to replacement cartridges for allergy testing systems used to determine a degree of reaction to one or more allergens by a subject in a minimally invasive manner.
BACKGROUNDIt is estimated that at least 50% of the population has some form of allergy. Approximately 20 million patients are currently tested for allergies using a number of techniques, for example, skin prick test, intradermal test, blood test, and skin patch test. Allergy test methods, such as the skin prick test are invasive and manual, involving depositing drops of many allergens on a subject's back, forearm, or other smooth body surface, labeling the region for identification, and then pricking the region with a needle to allow penetration of the allergy into the subject's body. The intradermal test is even more invasive, involving injecting a small amount of various allergens into the subject's skin. Due to the nature of these processes, large areas of the subject's skin tend to be affected.
Subjects undergoing these pin prick and intradermal tests then wait a prescribed period of time to allow the allergens a chance to react with their skin. Test regions must be large enough to easily be identified and evaluated by the human eye or by photographs which are then printed or enlarged. Although these forms of allergy testing often cover a large area of a patient's body, these manual determinations of allergic reaction provide the medical practitioner with a snapshot in time which has been shown to be useful in screening patients for allergic reactions.
Blood testing provides a highly invasive, yet possibly more convenient method of allergy testing. Unfortunately, blood testing does not surpass the sensitivity, specificity, and predictive value of the skin test. Blood test results are often dependent upon the laboratory which is performing the test. Blood testing for allergies is also a more expensive option.
Therefore, there is a need for a minimally invasive allergy testing system which does not need to cover large areas of a patient's skin, which can be automated to a large extent, which can be correlated to existing skin testing data, which offers more than a snapshot in time of an allergic reaction, which is economical, and which is easy to use and manufacture.
SUMMARYA replaceable cartridge for use in a minimally invasive allergy testing system is disclosed. The replaceable cartridge includes a microneedle array; encapsulated allergens, and
packaging to hold the microneedle array in alignment with the encapsulated allergens.
Another replaceable cartridge for use in a minimally invasive allergy testing system is disclosed. The replaceable cartridge includes a re-usable microneedle array, at least partially refillable encapsulated allergens, and packaging to hold the re-usable microneedle array in alignment with the at least partially refillable encapsulated allergens.
Another replaceable cartridge for use in a minimally invasive allergy testing system is disclosed. The replaceable cartridge includes a microneedle array for engagement with a separate set of encapsulated allergens, and packaging to hold the microneedle array in an alignment.
Another replaceable cartridge for use in a minimally invasive allergy testing system is disclosed. The replaceable cartridge includes refillable encapsulated allergens for engagement with a separate microneedle array; and packaging to hold the refillable encapsulated allergens in an alignment.
A method of manufacturing a replaceable cartridge for use in a minimally invasive allergy testing system is also disclosed. A formable layer is placed on a mold having cavities and vacuum lines coupled to the cavities. Heat is applied to the formable layer and a negative pressure is applied to the vacuum lines to wrap the cavities with the formable layer. The wrapped cavities are filled with allergens. The filled cavities are covered with a plastic cover to form an encapsulated allergen assembly. A removable seal is applied over the plastic cover. A microneedle array having a substrate and at least one microneedle is formed. An energy storage device is coupled to the substrate to form a microneedle array assembly. The encapsulated allergen assembly is coupled with the microneedle array assembly.
The claimed invention is compatible with a system and method to minimize the invasiveness of allergy testing, degree and area of reaction, testing time, general discomfort, and risk of infection. Another advantage of the claimed invention is that it enables a much smaller test area footprint when compared to prior testing devices. The much smaller footprint also simplifies and expedites the allergy testing process for a medical staff. The claimed invention is compatible with micro-fluidic technology, and therefore much smaller quantities of allergens may be dispensed, reducing the severity of the reaction for a patient, and possibly reducing the cost for the testing. The allergen dispensing process may also be automated in some embodiments, allowing for automated and quantified allergy reactivity data readout, thereby reducing uncertainty and subjectivity. A further advantage possible with automated embodiments is the ability to capture continuous or nearly continuous visual images of an allergy test site. This allows scientist and medical personnel the chance to study the time rate of change for certain allergic reactions, and better understand a patient's reaction and sensitivity. Overall, the minimally invasive allergy testing system enables a relatively fast allergy test cycle time, lowers the cost of such testing, and significantly reduces the chance for errors.
FIGS. 12D1-12D4 schematically illustrate different embodiments of gathering and analyzing allergy test data after the allergens have been applied by the allergy testing system in
The encapsulated allergens 24 have a corresponding set of allergens associated with the microneedles in the microneedle array 22. The microneedle array 22 and the encapsulated allergens 24 may be held in alignment with each other by a package 26. The minimally invasive allergy testing system 20 also has an activation system 28 which may be directly or indirectly coupled to the microneedle array 22 and/or the encapsulated allergens 24. The activation system 28 causes a skin of a test subject to be pricked, while releasing corresponding encapsulated allergens 24 into contact with the appropriate test prick.
There is a great degree of flexibility in configuring the activation system 28. In some embodiments, the activation system 28 can be a mechanical plunger or other mechanical system, which is pressed by a medical professional, or even the test subject themselves. In other embodiments, the activation system 28 can be a spring-loaded release which allows a predictable force to be applied to the microneedle array 22 as it pricks the subject's skin. Further embodiments of an allergy testing system 20 may have an activation system which is an electro-mechanical system, such as a solenoid, motor, or a micromechanical actuator.
The microneedle array 22, the encapsulated allergens 24, and/or the activation system 28 may be separate components of the allergy testing system 20. In the embodiment illustrated in
The microneedles in the microneedle array 22 may have a variety of geometries.
Any of the features of the microneedles in the embodiments of
A further embodiment of a microneedle 72 is schematically illustrated in
Referring to
An encapsulated set of allergens 88 associated with each hollow microneedle 78, is sandwiched between the substrate 76 and the plunger 90. The plunger 90 may be activated by an activation system (not shown), such as manual pressure, mechanical systems, electromechanical systems, piezoelectric, or a micromechanical actuator. Pressure applied to the plunger 90 causes the release of substrate 76 from resting stop 84 as well as the flow of allergens 88 through the channels associated with one of the hollow microneedles 78 positioned adjacent each encapsulated allergen. Motion of substrate 76 causes each of the microneedles 78 to protrude out of the package assembly 82 through the orifices 86 towards the patient's skin (not shown in this figure, but in this embodiment, the test subject would be above the allergy testing system 74 as oriented.) When the plunger is depressed far enough, the microneedles 78 pierce the patient's skin while mesas 80 fit into orifices 86 in package 82 to help increase travel and positional stability of the microneedles 78.
This embodiment also optionally has a thin sealing film 92 employed over a surface of the package assembly 82 to serve as a sterile layer between the subject's skin and the microneedles 78. Sealing film 92 may be removed before use or left behind on the patient's skin along with human readable, barcode, or other identifying marks 94. Such identifying marks have been discussed above with regard to previous embodiments.
Referring to
FIGS. 12D1-12D4 schematically illustrate different embodiments of gathering and analyzing allergy test data after the allergens have been applied by the allergy testing system in
FIG. 12D3 schematically illustrates an embodiment of an allergy analysis system 108 which can optionally be used in place of or in conjunction with manual evaluation methods. The allergy analysis system 108 includes a module 110 with imaging optics 112. The imaging optics 112 focuses images of the tested skin area on an image sensor 114. The image sensor 114 is coupled to an image analyzer or processor 116. The image analyzer 116 can analyze the captured images for color, shape, dimension, and location in the test field. Based on this analysis and correlation with what allergen was tested in which location, the analyzer 116 determines reactivity data for each allergen. The reactivity data, as well as the captured images may be stored, displayed, transmitted, and/or printed by the analyzer 116. Optionally, the analyzer may output this data to another processor for storage, display, further analysis, transmission, and/or printing. In the embodiment of FIG. 12D3, the analyzer 116 is directly coupled to the allergy analysis system 108. In other embodiments, the analyzer 116 may be remotely coupled to the analysis system 108 via a wireless or cabled link.
The image analyzer 116 may comprise a central processing unit (CPU) or processor and a memory which are coupled together by a bus or other link, although other numbers and types of components in other configurations and other types of systems, such as an application specific integrated circuit (ASIC) could be used. The processor may execute a program of stored instructions for one or more aspects of the claimed invention, including the method for determining a degree of reaction to one or more allergens as described and illustrated herein. The memory stores these programmed instructions for execution by the processor. A variety of different types of memory storage devices, such as random access memory (RAM) or a read only memory (ROM) in the system or a floppy disk, hard disk, CD ROM, or other computer readable medium which is read from and/or written to by a magnetic, optical, or other reading and/or writing system that is coupled to the processor, can be used for the memory to store these programmed instructions.
In the example of FIG. 12D3, the skin puncture site 118 shows a positive allergy reaction 106, while skin puncture sites 120, 122 show negative allergy reactions. The imaging module 110 should be placed in alignment with the original allergy testing device 102 (from
In other embodiments of an allergy testing system which have an allergy imaging analysis system 108, it may be important to determine topographic information when assessing reactivity to an allergen. In such embodiments, an extra set of imaging optics and an extra image sensor may be displaced laterally from the other optical system to obtain stereoscopic, parallax information about a given test location. Parallax information may in turn be used to calculate topographic profiles of test regions.
FIG. 12D4 schematically illustrates an embodiment of a minimally invasive allergy testing system 124 with an integrated imaging and analysis module 110. The microneedle array 126 and plunger 128 operate in similar fashion to the corresponding elements in
All of the minimally invasive allergy testing systems embodied herein, and their equivalents, are intended to be used with replaceable cartridges having the microneedle array and the encapsulated allergens.
The process begins,
Next,
In a parallel, preceding, or subsequent step,
Next, the allergen array assembly 168 from
Although the descriptions and figures of the embodiments described above show single needle arrays or one dimensional array systems, the claimed invention is easily extendible to two dimensions.
Having thus described several embodiments of the claimed invention, it will be rather apparent to those skilled in the art that the foregoing detailed disclosure is intended to be presented by way of example only, and is not limiting. Various alterations, improvements, and modifications will occur and are intended to those skilled in the art, though not expressly stated herein. These alterations, improvements, and modifications are intended to be suggested hereby, and are within the spirit and the scope of the claimed invention. Additionally, the recited order of the processing elements or sequences, or the use of numbers, letters, or other designations therefore, is not intended to limit the claimed processes to any order except as may be specified in the claims. Accordingly, the claimed invention is limited only by the following claims and equivalents thereto.
Claims
1. A replaceable cartridge for use in a minimally invasive allergy testing system, comprising:
- a microneedle array;
- encapsulated allergens; and
- packaging to hold the microneedle array in alignment with the encapsulated allergens.
2. The replaceable cartridge of claim 1, further comprising:
- a compressible stop coupled to the microneedle array and the packaging.
3. The replaceable cartridge of claim 1, wherein the microneedle array further comprises:
- a substrate; and
- at least one microneedle.
4. The replaceable cartridge of claim 3, wherein the alignment between the microneedle array and the encapsulated allergens is such that:
- the at least one microneedle can not pierce the encapsulated allergens; and
- the substrate can be pushed against the encapsulated allergens by the minimally invasive allergy testing system.
5. The replaceable cartridge of claim 3, wherein the alignment between the microneedle array and the encapsulated allergens is such that the at least one microneedle can pierce the encapsulated allergens.
6. The replaceable cartridge of claim 3, wherein the at least one microneedle further comprises a hollow needle.
7. The replaceable cartridge of claim 3, wherein the at least one microneedle further comprises a grooved needle.
8. The replaceable cartridge of claim 3, wherein the at least one microneedle further comprises a solid needle.
9. The replaceable cartridge of claim 3, wherein the at least one microneedle further comprises a corrugated needle.
10. The replaceable cartridge of claim 1, wherein the microneedle array comprises at least one needle of a first penetration depth and at least one needle of a second penetration depth which is different from the first penetration depth.
11. The replaceable cartridge of claim 1, wherein the microneedle array comprises at least one needle with a cross-section that is selected from the group consisting of: square, rectangular, triangular, and circular.
12. The replaceable cartridge of claim 1, wherein the microneedle array comprises at least one needle with a varying cross-section.
13. The replaceable cartridge of claim 1, wherein the microneedle array comprises a transparent material.
14. The replaceable cartridge of claim 1, wherein:
- the packaging further comprises orifices; and
- the microneedle array further comprises mesas which are aligned to slideably engage the orifices.
15. The replaceable cartridge of claim 1, further comprising a sealing layer for sealing the packaging to prevent contaminants from reaching the microneedle array.
16. The replacement cartridge of claim 15, wherein the sealing layer further comprises identifying marks.
17. The replacement cartridge of claim 16, wherein the identifying marks are selected from the group consisting of bar codes, graphics, and alphanumeric characters.
18. The replacement cartridge of claim 17, wherein the identifying marks are used for alignment by the minimally invasive allergy testing system.
19. The replacement cartridge of claim 17, wherein the identifying marks are used for identification of the allergens being tested.
20. The replacement cartridge of claim 17, wherein the identifying marks are used for identification of a patient.
21. A replaceable cartridge for use in a minimally invasive allergy testing system, comprising:
- a re-usable microneedle array;
- at least partially refillable encapsulated allergens; and
- packaging to hold the re-usable microneedle array in alignment with the at least partially refillable encapsulated allergens.
22. The replaceable cartridge of claim 21, wherein the re-usable microneedle array comprises a washable microneedle array.
23. The replaceable cartridge of claim 21, wherein the at least partially refillable encapsulated allergens comprise a sealing layer which may be replaced by a replacement sealing layer, the replacement sealing layer comprising an adhesive and measured allergens coupled to the layer for alignment with the microneedle array.
24. A replaceable cartridge for use in a minimally invasive allergy testing system, comprising:
- a microneedle array for engagement with a separate set of encapsulated allergens; and
- packaging to hold the microneedle array in an alignment.
25. A replaceable cartridge for use in a minimally invasive allergy testing system, comprising:
- refillable encapsulated allergens for engagement with a separate microneedle array; and
- packaging to hold the refillable encapsulated allergens in an alignment.
26. A method of manufacturing a replaceable cartridge for use in a minimally invasive allergy testing system, comprising:
- placing a formable layer on a mold having cavities and vacuum lines coupled to the cavities;
- applying heat to the formable layer and applying a negative pressure to the vacuum lines to wrap the cavities with the formable layer;
- filling the wrapped cavities with allergens;
- covering the filled cavities with a plastic cover to form an encapsulated allergen assembly;
- applying a removable seal over the plastic cover;
- forming a microneedle array having a substrate and at least one microneedle;
- coupling an energy storage device to the substrate to form a microneedle array assembly; and
- coupling the encapsulated allergen assembly with the microneedle array assembly.
27. The method of claim 26, wherein the formable layer comprises PVDC.
28. The method of claim 26, wherein the microneedle array is formed of glass, plastic, silicon, or metal.
29. The method of claim 26, wherein the energy storage device is selected from the group consisting of an elastomer spring, an metal spring, and a plastic spring.
30. A replaceable cartridge for use in a minimally invasive allergy testing system formed by the process of claim 26.
Type: Application
Filed: Jul 11, 2006
Publication Date: Sep 4, 2008
Inventors: Jose Mir (Rochester, NY), Dennis Roland Zander (Penfield, NY)
Application Number: 11/995,370
International Classification: A61M 37/00 (20060101); A61B 5/00 (20060101); B65B 43/00 (20060101);